— Reviews its Act of 2010
The Liberia Medicines and Health Products Regulatory Authority (LMHRA) has drafted eight new regulations and is undergoing a thorough review of the Authority’s Act of 2010 for potential amendments.
This drafting and revising process took place in Buchanan, Grand Bassa County over the course of a week.
The draft regulations cover various aspects, including defining roles and responsibilities, addressing complaints, establishing guidelines for product publication, setting standards for distribution and storage practices, and implementing risk-based product testing and post-marketing surveillance procedures.
Dr. Luke Bawo, LMHRA Managing Director, emphasized the necessity of updating the existing Act to address critical areas that were overlooked in the previous legislation.
The revisions of the authority’s Act aim to incorporate new regulatory responsibilities, align with international best practices, and uphold pharmaceutical regulatory standards.
He highlighted key issues that were absent in the current Act, including the decentralization of LMHRA’s operations, roles for Deputy Managing Director and Directors, improvements to the Quality Control Laboratory, and other administrative and regulatory matters.
“As we review these regulations and the Act, let’s collaborate to ensure they positively impact Liberia’s pharmaceutical sector over the next decade,” Dr. Bawo stated.
Among the drafted regulations for potential promulgation are those that define the roles, responsibilities, and functions of institutions involved in the regulatory system; regulations for addressing complaints and appeals against regulatory decisions; and guidelines for the publication of deferred and rejected products.
Additional regulations include those focused on qualifying reference standards, recognizing relevant decisions from other National Regulatory Authorities (NRAs) and international bodies, and implementing a risk-based approach to product testing.
Furthermore, regulations for Good Distribution Practice (GDP) and Good Storage Practice (GSP) inspections, as well as those mandating LMHRA to conduct risk-based post-marketing surveillance procedures, have also been drafted.
The objective is to ensure that the updated regulations and Act positively impact Liberia’s pharmaceutical sector in the coming years.
Dr. Michael Chu Nepay, LMHRA Programs & Planning Coordinator, outlined the retreat’s purpose of drafting new pharmaceutical regulations to ensure LMHRA enforces contemporary policies for regulating medicines and health products in Liberia.
LMHRA is the statutory body of the government responsible for ensuring the safety, efficacy, and quality of all medical products available in the country.
Dr. Bawo expressed appreciation to USP/PQM+, WHO, the Government of Liberia, the Ministry of Health, the Law Reform Commission, and LMHRA staff for their collaborative efforts.
Deputy Health Minister Malayah Chieyoe conveyed congratulations to all participants and reiterated the Ministry’s support for LMHRA in their endeavors to enhance health outcomes for Liberian citizens and align with the national health agenda.
In her closing remarks, LMHRA Deputy Managing Director Dr. Patricia Quaye-Freeman commended the participants for their collaborative efforts aimed at formulating regulations that ultimately aim to improve health outcomes for the Liberian populace upon enactment.
